Myeloproliferative NeoplasmNCT06159816
PREVALENCE STUDY OF PNH CLONES IN PATIENTS WITH NEOPLASIES
An observational study of Myeloproliferative Neoplasm, run by AUSL Romagna Rimini at 1 site in Italy.
Trial summary
Multicenter prevalence study of the PNH clone (paroxysmal hemoglobinuria nocturnal) in SMP Ph-. This multicenter, prospective study aims to evaluate the presence of an PNH clone in patients with a confirmed diagnosis of myeloproliferative neoplasia Phcon or without mutations in the 3 main genes involved in this… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Myeloproliferative Neoplasm
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2017to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosis of one of the following Ph-negative myeloproliferative neoplasms: polycythemia vera, essential thrombocythemia, idiopathic myelofibrosis, according to i WHO 2016 criteria
Who may be able to join
- Diagnosis of one of the following Ph-negative myeloproliferative neoplasms:
- polycythemia vera, essential thrombocythemia, idiopathic myelofibrosis, according to i WHO 2016 criteria
- Women or men, age ≥ 18 years.
- Willingness and ability to give written informed consent and adhere to study procedures.
- Availability of the result of the following molecular tests:
- JAK2-V617F mutation,
- JAK2 exon 12 in PV (if JAK2 negative) Cal-R, and MPL in MFI and TE (if JAK2 negative)
- Obvious signs of hemolysis (defined as LDH≥1.5 x ULN, reduced haptoglobin, reticulocytosis) when not related to the underlying disease or significantly changed compared to baseline values OR Detection of a thrombotic event (subsequent to diagnosis) OR Appearance or worsening of anemia OR Symptom change (appearance or worsening of signs or symptoms) in a stable disease context.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PREVALENCE STUDY OF PNH CLONES IN PATIENTS WITH NEOPLASIES MYELOPROLIFERATIVE PHILADELPHIA-NEGATIVE
Multicenter prevalence study of the PNH clone (paroxysmal hemoglobinuria nocturnal) in SMP Ph-. This multicenter, prospective study aims to evaluate the presence of an PNH clone in patients with a confirmed diagnosis of myeloproliferative neoplasia Phcon or without mutations in the 3 main genes involved in this disease (JAK2, MPL, and Cal-R),but showing signs of ongoing hemolysis or particular clinical conditions.
To this end, a multicolor flow cytometric test will be used to evaluate the presence of deficient GPI molecules in granulocytic, monocytic and other cells erythrocyte (flow cytometric test, based on the use of the FLAER reagent in peripheral blood samples).
Read more
The study will be conducted at clinical hematology centers in the wider area of the Romagna and at other Italian hematology clinical centers, where and analyzed the peripheral blood samples and clinical data to be included in the study.
The participating centers will carry out the flow cytometric diagnostic test at i own reference laboratories, while the biological material for subsequent studies genetic-molecular type (next generation sequencing) will be analyzed centrally at the Biosciences laboratory of the IRST IRCCS only for cases testing positive for the presence of the PNH clone. Clinical information will be collected for each patient enrolled in the study necessary for the classification of the case and all the laboratory data necessary for achievement of the objectives of the study. The main objective of the study is to evaluate the prevalence of PNH clones in patients with a confirmed diagnosis of myeloproliferative neoplasm Ph- with or without mutations affecting the 3 main genes involved in this disease (JAK2, MPL, e Cal-R), but showing signs of ongoing hemolysis or particular clinical conditions.
Secondary objectives of the study are:
- correlate the characteristics of the PNH clone with the clinical characteristics and laboratory of myeloproliferative neoplasms Ph- (the presence of phenomena thrombotics, the disease state, the DIPSS prognostic score index, and the state mutational).
- characterize the genomic architecture of the cases using NGS technology positive results
- Conditions
- Myeloproliferative Neoplasm
- Medical subject headings
- Myeloproliferative Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
the prevalence of PNH clones
evaluate the prevalence of PNH clones in patients with a confirmed diagnosis of myeloproliferative neoplasm Ph- with or without mutations affecting the 3 main genes involved in this disease (JAK2, MPL, e Cal-R), but showing signs of ongoing hemolysis or particular clinical conditions.
Measured: 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Nov 2017
- Primary completion1 Jan 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myeloproliferative NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- AUSL Romagna Rimini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159816
- Sponsor's protocol ID
- MyeloPNH
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
D'Addio A, Rondoni M, Salvucci M, Marconi G, Bonifacio M, Tanasi I, Perbellini O, Carli G, Tosi P, Tomassetti S, Poletti G, Massari E, Rosetti M, Fabbri E, Zingaretti C, Lucchesi A, Bochicchio MT, Simonetti G, Krampera M, Lanza F. PNH clones prevalence study in ph-negative myeloproliferative neoplasms: a multicenter Italian study. Ann Hematol. 2025 Sep;104(9):4487-4494. doi: 10.1007/s00277-025-06556-y. Epub 2025 Aug 22.
PubMed 40844514
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVALENCE STUDY OF PNH CLONES IN PATIENTS WITH NEOPLASIES MYELOPROLIFERATIVE PHILADELPHIA-NEGATIVE
- ClinicalTrials.gov ID
- NCT06159816
- Acronym / sponsor ID
- MyeloPNH
- Conditions
- Myeloproliferative Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- AUSL Romagna RiminiUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter prevalence study of the PNH clone (paroxysmal hemoglobinuria nocturnal) in SMP Ph-. This multicenter, prospective study aims to evaluate the presence of an PNH clone in patients with a confirmed diagnosis of myeloproliferative neoplasia Phcon or without mutations in the 3 main genes involved in this disease (JAK2, MPL, and Cal-R),but showing signs of ongoing hemolysis or particular clinical conditions.
To this end, a multicolor flow cytometric test will be used to evaluate the presence of deficient GPI molecules in granulocytic, monocytic and other cells erythrocyte (flow cytometric test, based on the use of the FLAER reagent in peripheral blood samples).
The study will be conducted at clinical hematology centers in the wider area of the Romagna and at other Italian hematology clinical centers, where and analyzed the peripheral blood samples and clinical data to be included in the study.
The participating centers will carry out the flow cytometric diagnostic test at i own reference laboratories, while the biological material for subsequent studies genetic-molecular type (next generation sequencing) will be analyzed centrally at the Biosciences laboratory of the IRST IRCCS only for cases testing positive for the presence of the PNH clone. Clinical information will be collected for each patient enrolled in the study necessary for the classification of the case and all the laboratory data necessary for achievement of the objectives of the study. The main objective of the study is to evaluate the prevalence of PNH clones in patients with a confirmed diagnosis of myeloproliferative neoplasm Ph- with or without mutations affecting the 3 main genes involved in this disease (JAK2, MPL, e Cal-R), but showing signs of ongoing hemolysis or particular clinical conditions.
Secondary objectives of the study are:
- correlate the characteristics of the PNH clone with the clinical characteristics and laboratory of myeloproliferative neoplasms Ph- (the presence of phenomena thrombotics, the disease state, the DIPSS prognostic score index, and the state mutational).
- characterize the genomic architecture of the cases using NGS technology positive results
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosis of one of the following Ph-negative myeloproliferative neoplasms: polycythemia vera, essential thrombocythemia, idiopathic myelofibrosis, according to i WHO 2016 criteria
Key inclusion criteria (8 listed)
- Diagnosis of one of the following Ph-negative myeloproliferative neoplasms:
- polycythemia vera, essential thrombocythemia, idiopathic myelofibrosis, according to i WHO 2016 criteria
- Women or men, age ≥ 18 years.
- Willingness and ability to give written informed consent and adhere to study procedures.
- Availability of the result of the following molecular tests:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the prevalence of PNH clones
Time frame: 2022
evaluate the prevalence of PNH clones in patients with a confirmed diagnosis of myeloproliferative neoplasm Ph- with or without mutations affecting the 3 main genes involved in this disease (JAK2, MPL, e Cal-R), but showing signs of ongoing hemolysis or particular clinical conditions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Derived from this study: PubMed 40844514D'Addio A, Rondoni M, Salvucci M, Marconi G, Bonifacio M, Tanasi I, Perbellini O, Carli G, Tosi P, Tomassetti S, Poletti G, Massari E, Rosetti M, Fabbri E, Zingaretti C, Lucchesi A, Bochicchio MT, Simonetti G, Krampera M, Lanza F. PNH clones prevalence study in ph-negative myeloproliferative neoplasms: a multicenter Italian study. Ann Hematol. 2025 Sep;104(9):4487-4494. doi: 10.1007/s00277-025-06556-y. Epub 2025 Aug 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloproliferative Neoplasm, run by AUSL Romagna Rimini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the prevalence of PNH clones (time frame: 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06159816, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.